1. Prospective assessment of diagnostic efficacy and safety of SonazoidTM and SonoVue® ultrasound contrast agents in patients with focal liver lesions
- Author
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Yi-Hong Chou, Bing Hu, Yukun Luo, Jae Young Lee, Yi Wang, Kun Chen, Yuxin Jiang, Xiaoyan Xie, Hongyan Zhai, Young Joon Lee, Ping Liang, Wen-Ping Wang, Christina Kalli, Lianfang Du, Hui-Xiong Xu, Ying Luan, Baoming Luo, Ja-Der Liang, and Ke Lv
- Subjects
medicine.medical_specialty ,Radiological and Ultrasound Technology ,business.industry ,Urology ,media_common.quotation_subject ,Ultrasound ,Gastroenterology ,Phases of clinical research ,Hepatology ,Confidence interval ,Internal medicine ,medicine ,Microbubbles ,Contrast (vision) ,Radiology, Nuclear Medicine and imaging ,In patient ,Radiology ,business ,media_common ,Contrast-enhanced ultrasound - Abstract
Objectives To assess the respective diagnostic value of Sonazoid™ and SonoVue® for characterizing FLLs as benign or malignant and the corresponding safety. Methods This prospective Phase 3 study was conducted at 17 centres in China and Korea (May 2014 to April 2015); 424 patients (20 to 80 years) with at least 1 untreated focal liver lesion (FLL) ( Results Sonazoid-enhanced and SonoVue-enhanced ultrasound provided a statistically significant improvement in specificity for all 3 readers comparing to unenhanced ultrasound (for Sonazoid: p = 0.0093, p = 0.002, 0.03, 0.12, respectively). Difference in accuracy improvement between the 2 groups was within the pre-specified non-inferiority margin of 20% for all 3 readers (6.1%, 95% CI: − 5.0 to 17.2; − 7.5%, 95% CI: − 18.4 to 3.5; − 0.3%, 95% CI: − 11.3 to 10.7). The diagnostic confidence level for all 3 readers increased with post-contrast images relative to pre-contrast images. Both contrast agents were well tolerated. Conclusion Results showed a similar efficacy for Sonazoid™ and SonoVue® in diagnosing FLLs as benign or malignant, and underlined the benefit of CEUS imaging over unenhanced ultrasound imaging in reaching a confident diagnosis without having to refer patients for additional imaging exams.
- Published
- 2021
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